Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Immunotherapy Clinical Trial

Official title:

Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035328
• Other study ID #: 069/2566(IRB3)
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: March 22, 2027

Study information

• Verified date: September 2023
• Source: Mahidol University
• Contact: Punchama Pacharn, MD
• Phone: 024197000
• Email: punchama[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT

Description:

All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT. The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 22, 2027
• Est. primary completion date: March 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 5-18 years old
• Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test
• Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT

Exclusion Criteria:

• Patient with low dose OIT protocol
• Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;
• Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)
• Patients with a developmental problem or mental disorder
• Active eosinophilic gastrointestinal disease in the past 2 years
• Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers
• Pregnancy or lactation
• Patient who could not visit clinic as protocol

Related Conditions & MeSH terms

• Hypersensitivity
• Immunotherapy
• Wheat Hypersensitivity

Intervention

Other:
• Wheat (Four times per week)
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term unresponsiveness rate	Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT.; Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period	13 months
Secondary	Specific IgE to wheat	Specific IgE to wheat	13 months
Secondary	Specific IgG4 to wheat	Specific IgG4 to wheat	13 months
Secondary	Changing in Body weight	Changing in Body weight in kilograms	13 months
Secondary	Compliance	Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption.	12 months
Secondary	Adverse reactions	Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system	13 months
Secondary	Quality of life by using FAQLQ-PF	Quality of life before and after enrollment by using FAQLQ-PF	13 months